FDA.reportPublic FDA data

Cardioplegia Pack

Primary DI
00803622119484
Brand
Cardioplegia Pack
Company
LIVANOVA USA, INC.
Model
Cardioplegia Pack
Published
2015-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K854640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854640000MODIFIED CORONARY CARDIOPLEGIA ADAPTORShiley, Inc.1986-02-10DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622119481PackageGS16In Commercial Distribution
00803622119484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362211948110803622119481
00803622119484008036221194848036221194840803622119484

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622164774Perfusion PackPerfusion Pack2026-10-06
00803622164781Perfusion PackPerfusion Pack2026-10-06
00803622164798Perfusion PackPerfusion Pack2026-10-06
00803622164866Perfusion PackPerfusion Pack2026-10-06
00803622164873Perfusion PackPerfusion Pack2026-10-06
00803622164880Perfusion PackPerfusion Pack2026-10-06
00803622164897Perfusion PackPerfusion Pack2026-10-06
00803622164903Perfusion PackPerfusion Pack2026-10-06
00803622164736Perfusion PackPerfusion Pack2026-09-29
00803622164743Perfusion PackPerfusion Pack2026-09-29
00803622164859Perfusion PackPerfusion Pack2026-09-29
00803622164651Perfusion PackPerfusion Pack2026-09-28
00803622164675Perfusion PackPerfusion Pack2026-09-28
00803622164682Perfusion PackPerfusion Pack2026-09-28
00803622164705Perfusion PackPerfusion Pack2026-09-28
00803622164712Perfusion PackPerfusion Pack2026-09-28
00803622164729Perfusion PackPerfusion Pack2026-09-28
00803622164767Perfusion PackPerfusion Pack2026-09-28
00803622164378Perfusion PackPerfusion Pack2026-09-22
00803622164477Perfusion PackPerfusion Pack2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00824846020073NAMEDTRONIC, INC.DWF2026-10-01
00840479402178enableCV QuickDraw™ Plus Venous CannulaENABLECV INC.DWF2026-08-27
00824846013419NAMEDTRONIC, INC.DWF2026-08-23
00824846013501NAMEDTRONIC, INC.DWF2026-08-23
00824846012962NAMEDTRONIC, INC.DWF2026-08-14
00824846013099NAMEDTRONIC, INC.DWF2026-08-14
00824846005445NAMEDTRONIC, INC.DWF2026-07-30
00824846005469NAMEDTRONIC, INC.DWF2026-07-30
00824846005667NAMEDTRONIC, INC.DWF2026-07-30
00824846006022NAMEDTRONIC, INC.DWF2026-07-30
00824846007944NAMEDTRONIC, INC.DWF2026-07-30
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26